A Phase 2/3 interventional study of Each treatment cycle is 28-days. Azacitidine 75 mg/m² is administered subcutaneously or intravenously on Days 1-7 of each cycle. Sonrotoclax is orally administered once daily on Days 1-14 within each in MDS (Myelodysplastic Syndrome), sponsored by The Affiliated People's Hospital of Ningbo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 2/3, Interventional, and Prevention
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To evaluate the efficacy and safety profile of sotoclax combined with azacitidine in newly diagnosed higher-risk MDS patients, including ORR, CR rate, PFS, OS and treatment-related adverse events
The Affiliated People's Hospital of Ningbo University is the lead sponsor of 11 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
High-risk MDS defined by any of the following risk stratification systems:
Adequate major organ function as defined below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with newly-diagnosed higher-risk MDS receive 28-day cycles of sonrotoclax (BGB-11417) plus azacitidine. Azacitidine 75 mg/m² is given subcutaneously or intravenously on Days 1-7. Sonrotoclax (RP2D 160 mg daily, Days 1-14 per cycle) undergoes 4-day dose ramp-up (20-40-80-160 mg) in Cycle 1, followed by full target dose in later cycles.
Drug: Each treatment cycle is 28-days. Azacitidine 75 mg/m² is administered subcutaneously or intravenously on Days 1-7 of each cycle. Sonrotoclax is orally administered once daily on Days 1-14 within each
Patients with newly-diagnosed higher-risk MDS receive 28-day cycles of sonrotoclax (BGB-11417) plus azacitidine. Azacitidine 75 mg/m² is given subcutaneously or intravenously on Days 1-7. Sonrotoclax (RP2D 160 mg daily, Days 1-14 per cycle) undergoes 4-day dose ramp-up (20-40-80-160 mg) in Cycle 1, followed by full target dose in later cycles.
Overall Response Rate (ORR)
Description: The proportion of participants achieving objective response (CR or PR) per response criteria. Unit of Measure: Proportion
Time frame: Up to 24 months
Complete Remission (CR) rate
Description: The proportion of participants achieving complete remission per response criteria. Unit of Measure: Proportion
Time frame: Up to 24 months
Duration of Response (DOR)
Description: Time from the first documented objective response to disease progression or death from any cause. Unit of Measure: Time (months)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Outcome Measure: Progression-Free Survival (PFS) Description: Time from randomization to disease progression or death from any cause. Unit of Measure: Time (months)
Time frame: Up to 36 months
Overall Survival (OS)
Outcome Measure: Overall Survival (OS) Description: Time from randomization to death from any cause. Unit of Measure: Time (months)
Time frame: Up to 36 months
Hematological/non-hematological adverse events
Description: Incidence of hematological and non-hematological adverse events, graded per CTCAE. Unit of Measure: Incidence (proportion)
Time frame: From first study treatment dose to 30 days after last dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2028; primary completion for Sep 2028, 0 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated People's Hospital of Ningbo University